A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)
详细描述
This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable and/or metastatic Hepatocellular Carcinoma
- •Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
- •Life expectancy of ≥12 weeks
- •At least one tumor lesion
- •At least 2 weeks since the end of prior systemic treatment
- •No evidence of pre-existing uncontrolled hypertension
- •ECOG 0 or 1
- •Adequate organ function
- •Not appropriate for curative therapy
- •Child A or B7 cirrhosis
- •CLIP score ≤ 4
排除标准
- •Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
- •Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
- •Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
- •Severe acute or chronic medical or psychiatric condition
- •Need for treatment with prohibited drugs
- •Has received local therapy to all measurable lesions
- •Stage B8 or higher liver cirrhosis
- •Ascites refractory to diuretic therapy
- •Clinically significant ECG abnormality
研究组 & 干预措施
Axitinib
Oral Axitinib (5mg, twice daily) will be administered to all patients
干预措施: Axitinib (AG-013736) (Drug)
结局指标
主要结局
Response rate
时间窗: Response rate assessed by CT scan at 16 weeks
次要结局
- Progression-free survival(At trial completion, 1.5 years)
- Quality of life(At completion of trial, 1.5 years)
- Feasibility(Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total))
- Overall survival(At the completion of trial, 1.5 years)
- Response rate comparison(Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(At completion of trial, 1.5 years)
- Number of Participants with Adverse Events as a Measure of Safety(At completion of trial, 1.5 years)